Monthly Archives: May 2022

Virtual visits (e.g., emails, phone calls, and videoconferencing) allow participants to interact with their trial team without the need for face-to-face meetings. They can be used in various settings but are frequently implemented to minimize travel requirements—for example, patients living in remote areas far from clinical centers. Or locations where frequent travel may present logistical challenges, such as international studies involving multi-country sites. Virtual contact is also increasingly being used in place of physical site visits to support the process of receiving informed consent and determining patient eligibility. Virtual contact is often combined with real-time technologies such as Web cameras and electronic patient diary apps to collect data. Virtual visits are becoming increasingly common in clinical research, but can they be implemented effectively? The Clinical Trials Transformation Initiative (CTTI)  The CTTI launched a multi-stakeholder, decentralized clinical trial addressing the best ways to implement remote patient data collection and monitoring — and provided researchers and regulators with the tools they need to support this new approach. At any rate, because of these combined factors, everyone involved in clinical research must understand how virtual visits work, their benefits and drawbacks, and what steps need to be taken to ensure that trials involving virtual visits adhere to ethical guidelines […] Virtual contact can take place either synchronously (e.g., using real-time technologies, such as web cams), or asynchronously (e.g., through electronic diaries).  Benefits of Virtual Visits Virtual contact can bridge geographical or organizational gaps in clinical trials and has been used in a wide range of therapeutic areas [5, 6]. Examples include psychiatric [7], oncology [8], and cardiovascular studies [9], as well as infectious disease research with tuberculosis and HIV cohorts. Virtual visits may also be efficient when patients are experiencing severe symptoms that prevent travel to the clinic, such as most recently with the pandemic.…

Clinical trials by their very nature are very complex. They are lengthy, costly, and often difficult to access. That makes the field ripe for real-world application, and by most accounts, decentralized clinical trials are the most promising way to implement them.  But challenges remain, especially when considering how to best implement them in the medical industry.  The potential of decentralization is significant, but it can be difficult to implement. Organizations must decide on the best way to use this approach and how to implement the technology without overextending budgets.The bottom line is that the current research model is flawed, but decentralized clinical trials are not necessarily the perfect solution. Let's explore these challenges and some solutions a little further. Challenge #1: Collecting Patient Data One of the major benefits of decentralized clinical trials is that they allow for a wider range of participation, as long as patients have appropriate access to the internet. In fact, this new model will likely be able to reach more people than traditional models due to its ease of use. However, it must be considered that not everyone has access to the internet. A decentralized clinical trial that cannot reach these populations will not be very effective at all. This is especially important in developing regions of the world where internet access might be more limited. It will also be important to consider how patient data are handled. Each person's medical history can provide valuable insight into the efficacy of a new drug or treatment. If this data is stored on a centralized server or database, it could be exploited by hackers or governments. New technology must be developed to prevent the loss of this important data and keep it secure. Challenge #2: Refinement of Data Decentralized trials present unique challenges related to patient safety…

Clinical trials are experiments that test new treatments and therapies. They can help researchers learn whether a drug is effective in treating a disease, or if it has harmful side effects with few benefits. These studies may impact the lives of thousands, even millions of people by providing more information on diseases and improving standards of care. Unfortunately, there are a number of misconceptions surrounding clinical trials.  Here we provide information from our own experiences to address some common concerns with clinical trial participation: 1) "I Don't Have Time" One of the most frequent reasons patients give for not participating is that they don't have time or cannot miss work. In fact, many clinical trials do not require participants to spend additional time beyond their normal activities outside of work or school. Some studies will even allow participants to continue taking their medications as prescribed, without interrupting their normal activities, during the clinical trial. 2) "I Don't Want To Risk Harm" In most cases of participation in a clinical study, a patient would not be exposed to new drugs or treatments if they did not have a disease or condition being studied. In rare instances where a placebo is being used – meaning there are no active ingredients – it is nearly always for cancer trials and under strict guidelines with oversight by an independent board responsible for protecting patients from harm (IRB).  3) "I Won't Get The Medication" This myth can often keep patients from participating in trials even when they may actually qualify and could benefit. Even though drugs tested in clinical trials are not readily available because they have not been approved by the FDA, many patients report getting access to new medications once they enroll in a trial. In fact, some companies make experimental drugs available…